MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207554
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw broke while tightening.
Additional Manufacturer Narrative
This implant has been used and is broken.The star hex head is undamaged.A portion of the threaded end was not returned.The distal tip and threads have been chewed up and have a diagonal fracture up the threads.This symptom indicates excess force was placed upon the implant.The physical condition indicates difficulty with proper insertion.No root cause related to the manufacturing of this device can be confirmed.

• Brand Name: SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7044783
• Report Number: 1219602-2017-01442
• Device Sequence Number: 1186262
• Product Code: MAI
• UDI-Device Identifier: 03596010426185
• UDI-Public: (01)03596010426185(17)220605(10)50667836
• Combination Product (Y/N): N
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/05/2022
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50667836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1